Research Compliance:

1. Research Compliance: An Overview of the Players and Issues Involved in Emory’s Research Compliance Programs

2. Major Players in Emory’s Research Compliance Programs: The Committees • Institutional Review Board (IRB): Responsible for oversight of human subjects research, including HIPAA compliance. • Institutional Animal Care and Use Committee (IACUC): Responsible for oversight of animal subjects research. • Institutional Health & Biosafety Committee (IHBC): Responsible for oversight of certain research involving recombinant DNA and involving certain hazardous agents. • Radiation Safety Committee: Responsible for oversight of certain research involving radiation and/or radioactive materials. • Conflict of Interest (COI) Committee(s): Responsible for review/management of conflicts of interest that may affect research.

3. Major Players in Emory Research Compliance Program: Administrative Offices • Office of Research Compliance (ORC): Monitors compliance activities and serves as resource for various units’ compliance operations. Director also serves as Privacy Officer under HIPAA. • Office of Sponsored Programs (OSP): Responsible for pre-award activities regarding grants and contracts. • Office of Grants and Contracts Accounting: Responsible for post-award activities regarding grants and contracts. • Environmental Health & Safety Office (EHSO): Works with units on issues of laboratory safety, chemical and waste management, occupational health and safety issues, etc. • School of Medicine Administration: Has personnel responsible for COI issues, research integrity issues, etc.

4. Major Compliance Program Components • Human Subjects Protections • Animal Subject Protections • Responsible Conduct of Research • Confidentiality and Privacy • Laboratory Health and Safety • Fiscal Oversight of Studies

5. Component Breakdown:Human Subjects Protections • Regulators and Regulations: • Office for Human Research Protections (OHRP), http://www.hhs.gov/ohrp/; 45 CFR Part 46 • Food and Drug Admin. (FDA), http://www.fda.gov/; 21 CFR Parts 50 & 56 • Chief Emory Contact Unit: Emory IRB, http://www.emory.edu/IRB/

6. Key Points: Human Subjects Protections • Unless a specific regulatory exemption applies, the IRB must review and approve all research that involves human subjects before the research begins. • The IRB is responsible for initial review and continuing oversight of human subjects research. • Unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with the federal regulations or the Emory IRB’s requirements or determinations must be reported to the IRB.

7. Component Breakdown: Animal Subjects Protections • Regulators and Regulations: • U.S. Dept. of Agriculture (USDA), http://www.aphis.usda.gov/subjects/animal_welfare/; Animal Welfare Act & regulations, 9 CFR Part 2, Subpart C • NIH Office of Laboratory Animal Welfare, http://grants.nih.gov/grants/olaw/olaw.htm; Policy on Humane Care & Use of Laboratory Animals at http://grants.nih.gov/grants/olaw/references/phspol.htm and Guide for Care and Use of Laboratory Animals at http://www.nap.edu/readingroom/books/labrats/ • Assoc. for Assessment & Accreditation of Laboratory Animal Care International (AAALAC), http://www.aaalac.org/programstatus/index.cfm; Rules of Accreditation • Chief Emory Contact Unit: Emory IACUC, http://www.emory.edu/IACUC/

8. Key Points: Animal Subjects Protections • IACUC approval required before research using animals is initiated. • IACUC performs initial and continuing review and approval. • IACUC inspects areas in which animals are housed or certain animal procedures are performed on a semi-annual basis.

9. Component Breakdown: Responsible Conduct of Research • Regulators & Regulations: • HHS Office of Research Integrity (ORI), http://ori.dhhs.gov/; 42 CFR Part 93 (policies on research misconduct) • National Science Foundation (NSF), http://www.nsf.gov/; 45 CFR Part 689 (policies on research misconduct) • NIH Office of Extramural Research, http://grants1.nih.gov/grants/policy/coi/index.htm (policies on conflict of interest) • Chief Emory Contact Unit: Office of Research Compliance, http://www.orc.emory.edu/ and individual schools for COI questions.

10. Key Points: Responsible Conduct of Research • Prohibition of fraud, falsification and plagiarism. • Ensuring data accuracy, completeness and integrity. • Inquiry and investigation process handled by each school in connection with Office of Research Compliance.

11. Component Breakdown: Confidentiality and Privacy • Regulators & Regulations: • HHS Office of Civil Rights – HIPAA privacy rule enforcement -- http://www.hhs.gov/ocr/hipaa/; 45 CFR Parts 160 & 164 (privacy rule) • HHS Centers for Medicare and Medicaid Services (CMS) – HIPAA security rule enforcement -- http://www.cms.hhs.gov/SecurityStandard/; 45 CFR Parts 164, Subpart C (security rule). • NIH -- Certificates of Confidentiality -- http://grants1.nih.gov/grants/policy/coc/index.htm, 42 U.S.C. Section 2412(d). • Chief Emory Contact Unit: Office of Research Compliance, http://www.orc.emory.edu/ Chief

12. Key Points: Confidentiality & Privacy • HIPAA privacy and security regulations apply to Emory’s Covered Components, i.e., EHC, EH, EC, CLH, SOM, SON, SOPH, Yerkes, Student Health, Psychological & Counseling Centers. • Privacy Rule focuses on Protected Health Information (PHI). • Emory IRB serves as Institutional Privacy Board for all research that involves the use of PHI obtained from or used by persons in Emory’s Covered Components.

13. Component Breakdown: Laboratory Health and Safety • Regulators and Regulations: • Occupational Health & Safety Admin. (OSHA), http://www.osha.gov/; 29 CFR Part 1910. • Environmental Protection Agency (EPA), http://www.epa.gov/; 40 CFR Parts 260-65. • NIH Office of Biotechnology Activities (OBA), http://www4.od.nih.gov/oba/; NIH Guidelines for Recombinant DNA and Gene Transfer at http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html. • Centers for Disease Control & Prevention (CDC), http://www.cdc.gov/; 42 CFR Part 73 (select agents). • State of Georgia Regulators including the Department of Natural Resources. • Chief Emory Contact Unit: Environmental Health & Safety Office (EHSO), http://www.ehso.emory.edu/

14. Key Points: Laboratory Health and Safety • Requirements for review of certain types of research, e.g., IHBC must review research involving recombinant DNA and research involving Select Agents. • Requirements for ensuring safety of lab workers, e.g., training requirements, personal protective equipment requirements. • Requirements for use and disposal of certain materials, e.g., materials containing blood or body fluids; radioactive materials; certain chemical waste; controlled substances.

15. Component Breakdown: Fiscal Oversight of Studies • Regulators & Regulations: Each funding agency has its own regulations and requirements. There are also overall requirements that may apply to federal or state funded research. • Chief Emory Contact Units: • Pre-award: Office of Sponsored Programs, http://www.osp.emory.edu/office/ • Post-award: Office of Grants & Contracts Accounting, http://www.ogca.emory.edu/office/

16. Key Points: Fiscal Oversight of Studies • Get familiar with the funding agency’s requirements, including any reporting requirements. • Have some mechanism in place for oversight of research taking place at other sites. • Documentation is critical.

17. Asking Questions & Reporting Compliance Concerns • Compliance questions can be directed to individual units with compliance responsibility for area in question or to Office of Research Compliance. • Concerns can be reported to departments, schools, Office of Research Compliance, or to Emory Trust Line @ 1-888-550-8850. • Trust Line allows for anonymous reporting through hotline manned by independent company. See FAQ at http://emory.hr.emory.edu/iad.nsf/.

18. Contact Information for Compliance Office • Emory University Office of Research Compliance • Ste. 510, 1784 N. Decatur Rd. • Atlanta, GA 30322 • Phone: (404) 727-2398 • FAX: (404) 727-2328 • Director: Kris West, J.D.